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Comparison of the Efficacy and Safety of Ivermectin to Permethrin
This study has been completed.
Sponsor:
University Ghent
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00262418
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
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Purpose
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies
| Condition | Intervention | Phase |
|---|---|---|
| Scabies | Drug: Administration of ivermectin or permethrin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies |
Resource links provided by NLM:
Further study details as provided by University Ghent:
Primary Outcome Measures:
- Clinical healing of the skin injuries [ Time Frame: on day28 ]
Secondary Outcome Measures:
- Decrease of itching [ Time Frame: on day28 ]
- Amelioration of the life quality [ Time Frame: on day28 ]
- Number and gravity of adverse events
| Enrollment: | 160 |
| Study Start Date: | July 2004 |
| Study Completion Date: | May 2005 |
Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28
Eligibility| Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
At least one of the following inclusion criteria:
- Scabies tunnels
- Positive microscopic examination (acarids, faeces or ova)
At least two of the three following inclusion criteria:
- Non-specific injuries with a typical distribution pattern
- Serious itching which increases during the night
- Family or contacts with similar complaints
Exclusion Criteria:
- Treatment for scabies < 4 weeks ago
- Treatment with corticoids < 1 week ago
- Pregnancy
- Breast-feeding
- HIV
- Serious immunodepressive patients
- Sensitivity or allergy to one of the components of the study medication
- Damage of the central nerve system
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418
Locations
| Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
Sponsors and Collaborators
University Ghent
Investigators
| Principal Investigator: | Jean-Marie Naeyaert, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00262418 History of Changes |
| Other Study ID Numbers: |
2004/212 |
| Study First Received: | December 4, 2005 |
| Last Updated: | December 19, 2007 |
Additional relevant MeSH terms:
|
Scabies Mite Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Skin Diseases, Infectious Skin Diseases |
Ivermectin Permethrin Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 24, 2017